Study Startup Specialist I

Role Summary

Take your career to the next level and be involved in study startup processes in the US. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.

Responsibilities

You will

• Supports all processes critical for site activation.
• Supports Feasibility department with feasibility research and site identification process.
• Maintains project-specific tracking systems and electronic Trial Master File (eTMF) throughout study startup phase.
• Provides administrative support with site agreement and budgets.
• Assists with site documents collection for IRB/IEC submission and/or IP-RED process.
• Provides progress updates to all concerned functions.
• Identifies project-specific issues and escalates as outlined in the project specific Communication Plan.
• Supports preparation of study dossiers to sites and competent authorities.
• Supports preparation of IP-RED packages.
• Ensures exchange of information and documentation with investigational sites, off -site facilities and vendors throughout study startup phase.
• Additional responsibilities may include collecting documents in preparation for audits on a country-region level.
• College/University degree or an equivalent combination of education, training and experience
• At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience
• Communication and organizational skills
• Ability to negotiate and build relationships at all levels
• Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
• For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
• PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

About the Company

Why Join PSI?

At PSI, we believe exceptional people deserve an exceptional workplace.

When you join PSI, you'll benefit from

A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs.

A unique leadership-focused CRA role with minimal travel and little to no routine site assignments.

Opportunities to mentor other CRAs and expand your leadership skills.

A collaborative, people-first culture where employees are genuinely supported.

Career development opportunities across a growing global organization.

The chance to contribute to innovative clinical research that improves patients' lives.

We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global Contract Research Organization with more than 3,000 employees dedicated to advancing medical science and bringing new therapies to patients worldwide.

In an industry shaped by mergers, acquisitions, and restructures, PSI stands apart. We have remained privately held, have never undergone a merger or acquisition, and have never experienced company-wide layoffs. Our long-term stability allows us to invest in our people, foster meaningful careers, and build lasting partnerships with our clients.

If you're looking for a collaborative organization where you can continue to grow while making a meaningful impact, PSI is the right place for you.